Pain management system

ABSTRACT

A central pain management system (Algotron) comprising the relationships involving the use of a pain treatment system (Remote Algotron), novel pain treatment device (Neuraxial Transcutaneous Electrical Nerve Stimulator NTENS), Central Computer, Clinical Resource comprising a clinical-outcomes knowledgebase (AlgoNeuroMatrix), a Clinical Triage Resource, Protocol Generator and Stimulation Pattern Generator, the Algotron also includes combinations of network architectures to coordinate between a patient, Licensee/Provider, Licensee/Provider Computer, internet and real-time data point streaming are disclosed.

BACKGROUND OF THE DISCLOSURE

1. Technical Field of the Invention

A central pain management system (Algotron) comprising the relationshipsinvolving the use of a pain treatment system (Remote Algotron), novelpain treatment device (Neuraxial Transcutaneous Electrical NerveStimulator NTENS), Central Computer, Clinical Resource comprising aClinical Triage Resource, a clinical-outcomes knowledgebase(AlgoNeuroMatrix), Protocol Generator and Stimulation Pattern Generator,the Algotron also includes combinations of network architectures tocoordinate between a patient, Licensee/Provider, Licensee/ProviderComputer, internet and real-time data point streaming are disclosed.

2. Description of the Prior Art

U.S. Pat. No. 7,489,964, of Suffin, et al, which issued on Feb. 10,2009, discloses a method and system for utilizing neurophysiologicinformation obtained by techniques such as quantitativeelectroencephalography (QEEG), electrode recordings, MRI inappropriately matching patients with therapeutic entities. The methodenables utilization of neurophysiologic information, notwithstanding itsweak correlation with extant diagnostic schemes for mental disorders,for safer and expeditious treatment for mental disorders, discoveringnew applications for therapeutic entities, improved testing of candidatetherapeutic entities, inferring the presence or absence of a desirableresponse to a treatment, and deducing the mode of action of one or moretherapeutic entities. In particular, methods for effectively comparingneurophysiologic information relative to a reference set are disclosedalong with database-based tools for deducing therapeutic entity actionson particular patients such that these tools are readily accessible toremote users. This reference however does not realize the treatments sodesperately needed by pain patients.

U.S. Pat. No. 7,117,034 of Kronberg which issued on Oct. 3, 2006discloses a method for generating an electrical signal for use inbiomedical applications, including two timing-interval generators, eachoptionally driving a multistep sequencer; analog, digital or hybridmeans for combining the resulting timed signals into a complexelectrical signal; optional filtering means for blocking direct current,removing selected frequency components from the resulting signal, and/orproviding voltage step-up if needed; and conductive means for couplingthe resulting signal to a human or animal body, food, beverage or otherliquid, cell or tissue culture, or pharmaceutical material, in order torelieve pain, stimulate healing or growth, enhance the production ofspecific biochemicals, or devitalize selected types of organisms. Theproblem with this is that it does not possess adequate real-time patientmonitoring and does not posses the ‘intermodality’ quality that isneeded, that is to be simultaneously compatible with simultaneous usagewith all contemporaneous mainstream treatment modalities.

There is a plethora of electrotherapeutic devices on the market.Unfortunately, these other devices do not possess adequate real-timepatient monitoring and do not posses the ‘intermodality’ quality(described above) of this patent, as well as, other criticaldeficiencies. Additionally, they may be promoting adverseneuromodulatory effects that simply promote the ‘masking’ of painperception possibly at the expense of true remediation. In fact, themechanisms employed to perfect the ‘masking’ of pain perception areknown to often be responsible for ‘maladaptive’ neuroplasticity thatcontributes to the ‘chronification’ of pain. [Flor, et al '94] Ourpatent's usage is designed to produce true remediation, not replicate aniatrogenic dependence on a modality that can be viewed in one sense asthe temporizing effort of administering opioids.

SUMMARY OF THE INVENTION

The prescribed use of this patent, a pain treatment medical device andrelated methodology has together produced an effective treatment for abroad range of pain patients. It is an object of the present inventionto provide a pain management system (Algotron), including but notlimited to such devices as the NTENS that can therapeutically coordinatethe process of managing various pain treatment components across anetwork of professional providers, and clinical resources, to manage andtreat various forms of presenting pain to improve clinical outcomes forpatients being treated for pain.

It is another object of the present invention to, where possible,automate the process to maximize the positive outcome for the individualpatients, while doing so efficiently and at significantly reduced costcompared to existing treatment modalities and/or regimens to the patientand the health care system.

These and other objectives of the present invention will become apparentto those skilled in this art upon a careful review of thesespecifications, drawings and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of a preferred embodiment and the best modecontemplated by the inventor is for a pain management system.

FIG. 2 is a block diagram of the network architecture and internetcommunications system.

FIG. 3 is a diagram of the components of one of many electrodeapplication devices.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIGS. 1 and 2, a central pain management system (Algotron)(10) comprising the relationships involving the use of a pain treatmentsystem (Remote Algotron) (15), novel pain treatment device (NeuraxialTranscutaneous Electrical Nerve Stimulator—NTENS) (18), Central Computer(48), Clinical Resource (47) comprising a clinical-outcomesknowledgebase (AlgoNeuroMatrix) (14), a Clinical Triage Resource (13),Protocol Generator (40) and Stimulation Pattern Generator (41), theAlgotron (10) also includes combinations of network architectures tocoordinate between a patient (11), Licensee/Provider (12),Licensee/Provider Computer (33), internet (16) and real-time data pointstreaming are disclosed.

FIG. 1 is a block diagram of a preferred embodiment and the best modecontemplated by the inventor is for a pain management system (Algotron)(10) comprising the relationships involving the use of real-time datapoint streaming, Internet (16) and combinations of network architectures(CNA) (17) to coordinate between a Patient (11), Licensee/Provider (12),Licensee/Provider Computer (33), a Clinical Triage Resource (13),Central Computer (48) clinical-outcomes knowledgebase, AlgoNeuroMatrix(14), pain treatment system, Remote Algotron (15) and a pain treatmentdevice, Neuraxial Transcutaneous Electrical Nerve Stimulator NTENS (18).

FIG. 2 is a block diagram of the Patient (11), Licensee/Provider (12),Licensee/Provider Computer (33), Remote Algotron (15), Central Computer(48). and Clinical Resource (47) communicate with one anothersimultaneously by way of the Internet (16) and combinations of networkarchitectures (CNA) (17).

FIG. 3 is a diagram of the components of one of many electrodeapplication devices (20) as being provider acknowledgement button (50),light emitting diodes (51, 52, 53), stimulation delivery end (54) andNTENS attachment end (55).

Referring to FIG. 2, the Remote Algotron (15) as currently conceivedencompasses an input/output (I/O) interface (32), several levels ofbiometric access security levels (19) identifying and confirming boththe patient and provider, a pain treatment device NTENS (18), multipleautonomic nervous system (ANS monitoring) channels (26), 4electromyography channels (EMG ×4 monitoring) (56), electrodermalimpedance monitoring (34) for constant current assurance, processor(35), ROM/RAM (36), display (37), storage device (38) and controlprogram (39). The NTENS (18), in its function, is comprised of certainstimulation features such as amplitude (21), waveform (22), frequency(23), pulse width (24) and polarity (25). An integral part of the NTENSdesign function is the stimulation pattern generator (41) found in FIG.2 with in the Clinical Resource (47) and impedance monitoring subsystem(34) for the assurance of constant current generation. ANS monitoring(26) consists of multiple channels for galvanic skin response (GSR)(27), heart rate (HR) (28), cardiac rhythm strip (RS) (29), pulseoximetry (SPO2) (30) and 5 temperature monitors (Temp ×5) (31). TheCentral computer (48) is comprised of an (I/O) interface (49), processor(42), ROM/RAM (43), display (44), storage device (45), keyboard, mouse,audio capacity and control program (46). The Clinical Resource (47)includes the Clinical Triage Resource (13), AlgoNeuroMatrix (14),protocol generator (40) and stimulation pattern generator (41)

Referring to FIG. 1, it is assumed that the Provider/Licensee Computer(33) will be standardly configured and possess a display and audiocapacity as well as a keyboard and mouse. The collective function of theLicensee/Provider Computer (33) is to provide functional interfacingwith the Remote Alorton's (15) user interface. The preferred embodimentcomprises the Licensee/Provider Computer (33) to be a battery poweredlap top. However, the Remote Algotron (15) provides patient electricalisolation so that a desk top computer can be used.

Referring to FIG. 2, in accordance with the present invention, theremote treating Licensee/Provider (12) will enter data of various typesas prompted by the Clinical Resource (47) through the remote computer(33) connected to the Remote Algotron. As part of the patient visitregistration (both initial and follow-ups) the Clinical Resource (47)may request specific data based on the individual presenting clinicalprofile, this data may include but not be limited to current workingdiagnoses, presenting symptomatology, physical examination findings, aswell as, data from other treatment disciplines, i.e. chiropractic,traditional Chinese Medicine, etc. Additionally, related case historytreatment modalities and pertinent psychosocial functioning, withspecial emphasis on neuropsychological testing may be requested.Further, pertinent historic data from diagnostic modalities and currentand past pharmacologic approaches may also be requested. Thedetermination as to exactly what primary and/or additional data will berequested will be the responsibility of the Clinical Resource (47) on acase-by-case basis. Data inquiries from the Clinical Resource (47) willbe displayed on the Licensee's/Provider's computer (33). TheLicensee/Provider (12) will have an opportunity to voluntarily provideadditional data deemed pertinent that has not been requested by theClinical Resource (47). Once the patient has been established in theLicensee/Provider (12) practice and registered with the ClinicalResource (47), that is to include appropriate biometric identificationwithin the system, interim treatment progress reports obtained prior toeach additional new visit weigh heavily in this process and will serveas a co-contributing factor forming the basis for longitudinal patientmanagement and reporting.

Referring to FIG. 2, program information to include treatment protocolsis obtained from the Clinical Resource (47) and the Central Computer(48) and transmitted to the Remote Algotron (15) and there after passedthrough to the control program (39) of the Remote Algotron (15) andstored in Remote Algotron's (15) storage device (38). In use, theprotocol instructions are retrieved from the Clinical Resource (47), ona single usage basis, from the storage device (38) and used to drive theNTENS (18) component of the Remote Algotron (15).

Referring to FIGS. 1 and/or 2, fully automated progress reporting isemployed and therapeutic trend analysis will be available to theLicensee/Provider (12) both to the screen of their remote computerand/or for printing for various other reasons, such as patient's chartdeposit, sending of same to respective insurance carriers, etc.

Referring to FIG. 2, the Remote Algotron (15) is comprised of aconventional processor (35) with sufficient capacity to perform thefunctions of the system. The processor (35) is in electricalcommunication with a read only memory (ROM) (36), which provides initialconfiguration and verification of the Remote Algotron (15) upon start upof the system. The processor (35) is also in further electricalcommunication with a random access memory (RAM) (36), which providesshort-term storage of data and programming for the processor (35). Theprocessor (35) and the ROM/RAM (36) are defined as the centralprocessing unit of the Remote Algotron (15). The Remote Algotron (15)also is comprised of a storage device (38), which is a computer usablemedium with long-term memory storage capability. The Remote Algotron(15) is powered by 120 volt AC and provides for electrical patientisolation.

Referring to FIG. 2, there are two critical feedback subsystems asillustrated in FIG. 2, real-time ANS monitoring (26) and electrodermalimpedance level monitoring (34). On a real-time basis, this ANSmonitoring information is as impactful to the ongoing treatment of thepatient as is the monitoring of the varying electrodermal impedancelevels (34) for the maintenance of prescribed stimulation output levels,i.e., constant current generation. In the preferred embodiment therewill be real-time ANS monitoring (26), to include galvanic skin response(GSR) (27), cardiac rhythm strip (RS) (29), heart rate (HR) (28), pulseoximetry (SPO2) (30) and central core and extremity temperatures (temp×5) (31), culminating into multiple real-time data point streams with acommensurate number of channels. To insure constant level stimulation asprovided by the NTENS (18), the real-time monitoring of electrodeimpedance values is provided for by the relevant circuitry (34) of theNTENS (18) in conjunction with that of the Remote Algotron (15),illustrated in FIG. 2.

Referring to FIG. 2, there are 4 channels of real-time electromyography(EMG) (56) for targeted neuromuscular monitoring. These channels employsurface electromyography beneficial in the diagnosis and treatment formany neuromuscular clinical issues such as, myofacial trigger pointsyndromes, maladaptive biomechanics, etc. These data points can be usedto derive real-time assessment of ongoing treatment regimens.

Referring to FIG. 2, the NTENS (18) is a fully functional, programmableelectro-therapy device employable by a Remote Algotron (15) respondingto treatment protocols generated by the Clinical Resource (47) and moreparticularly by the protocol generator (40) for treatment of theetiology of a patient's underlying condition that results in theirvarying report of pain and related disabilities not just masking theirperception of pain. In it's preferred embodiment, the NTENS (18) caneither be battery powered for wireless configuration or receive itspower from the Remote Algotron (15) in a wired configuration. Thestimulation output of the device is as follows: a.) tightly modulatedcomplex waveform (22), b.) an asymmetrical sum zero delivery windowpattern, tightly modulated square waveform (22), c.) alternatingpolarities (25), d.) tightly modulated frequency (23) pulse trains andburst patterns and e.) sets of electrode outputs (a minimum of twochannels, two electrodes per channel) with multiple channels commonlyrequired. The varying patterns include burst patterns and varyinglengths of trains of varying amplitudes (21) ranging from 0.1 microampsto 60 milliamps with a 0.1 microamp resolution. By design intent thevarying asymmetric stimulation pattern generator (41), as well asvarying levels of amplitude (21) and frequencies (23) are criticallycoordinated. Due to the sub-Markovian, neurophysiologic emergentproperties of the targeted treatment areas, while under treatment, thecoordination as previously referenced of these two aspects ofapplication is design specific and critical to patient outcome. Asstated previously, the stimulation pattern is a complex waveform (22).It is an asymmetrical stimulation pattern, tightly modulated squarewaveform (22) with tightly modulated varying pulse widths (24) andalternating polarities (25) of current to a sum zero over each treatmentdelivery window. A delivery window is defined as the length of time of agiven sequenced placement of stimulation by the NTENS (18) as defined bythe particular protocol in use.

Referring to FIG. 2, the number of treatment delivery windows isdictated by the prescribed treatment protocol generated by the ClinicalResource (47) and transmitted to the Remote Algotron (15) for eachindividual visit. The resultant stimulation pattern is designed to havea tightly modulated varying pulse width (24) from 0.1 microseconds to500 milliseconds with a 0.1 microsecond resolution. Depending on theindividual prescribed protocol, the variable treatment delivery windowsrange from a burst pattern of 0.1 millisecond to varying asymmetrictrain patterns of stimulation totaling up to ten (10) minutes perplacement site. Again, depending on the presenting symptomatology andevolution of the clinical course, the resultant protocol prescribes thelength of each treatment delivery window, as well as the total number oftreatment delivery widows per stimulation site subject to prescribedsequencing requirements. Tightly modulated frequencies (23) utilize arange from 0.1 to 5 htz. Frequencies greater than 5 htz has been shownto increase excitotoxicity. The electrostimulation is delivered througha combination of wired or wireless electrodes, handheld probeelectrodes, electrode gloves and/or skin affixed electrodes such as butnot limited to silver-silver chloride, tin or gold disk or adhesive padelectrodes or active (both dry and non-dry) electrodes. One of manyelectrode application devices, probes (20), is illustrated in FIG. 3.

Referring to FIG. 2, it should be noted that the Remote Algotron (15)may be located at any location of the respective Licensee/Provider (12)having access to a communications network with continuous broadbandinternet (16) access. It should also be noted that a plurality of RemoteAlgotrons (15) could communicate with a plurality of protocol generators(40). The combinations of network architectures includes but are notlimited to: local area networks, wide area networks, televisionnetworks, transmitted broadband or cable, public switched telephonenetworks and integrated services digital networks or RF links.

Referring to FIG. 2, the Remote Algotron (15) will be in electricalconnection via security layers (19) to include but not be limited to oneor more biometric identifying protocols such as facial recognition,fingerprint identification, iris scans, etc, to the Central Computer(48). The security layers and biometric identification protocols (19)are comprised any contemporaneous standard security scheme ortechnology. The security layer (19) may be used for all communicationsystem-wide. This will, for example, include: Licensees/Providers (12),patients (11), Remote Algotron (15), all pain treatment componentdevices such as the NTENS (18), remote Licensee/Provider Computer (33),Central Computer (48), and Clinical Resource (47). In one embodiment theRemote Algotron (15) with input/output (I/O) interface (32) will be indirect electrical communication through the security layer (19) viaInternet (16) (wired or wireless) and/or CNA (17) connections to the(I/O) interface (49) of the Central Computer (48).

Referring to FIGS. 1, 2 and 3, as originally issued by the ClinicalResource (47) when the existing protocol must be amended by the treatingLicensee/Provider (12) during active treatment, the amended protocol asdetermined by the Clinical Resource (47) will be displayed on the remotecomputer of the treating provider (33) visually with a simultaneousaudible alert accordingly. To the extent the recommended change iscontrolled by the protocol these changes will occur automatically. As anadditional safety feature, one conceived device, probes (20) will havelight emitting diodes (51,52,53) conspicuously placed to provide thetreating provider with a visual alert as to changes required by theprotocol. FIG. 3 illustrates one of several anticipated configurationsof stimulation electrodes utilizing a set of probes (20) connected tothe NTENS (18). Demonstrated is a series of light emitting diodes (51,52, 53) that are of two colors, either green or red. FIG. 3 illustratesonly three of the possible 13 designated functions. Should the diode(51,52,53) be emitting a green color, the treating provider caninterpret same as the function assigned to that diode (51,52,53) asbeing performed according to protocol. For example, in FIG. 3 the firstdiode (51) if green may indicate that the pain management system(Algotron) (10), to include the pain treatment system (Remote Algotron)(15) is functioning as designed, including as it pertains to the demandsof the particular driving protocol. However, if the color is red thenthe treating provider is alerted to the malfunction of the systemallowing for investigation as to the source of the problem beforeproceeding with treatment. Continuing with the example, the second lightemitting diode (52) if green may indicate compliance with protocolrequired impedance levels (34), while if red the noncompliance withsame. The third diode (53) may have one of the ANS monitoring (26)functions assigned to it. In any event, the NTENS (18) will cease tofunction until the treating provider acknowledges said alert. This maybe accomplished, for example, by depressing the appropriate button (50)as illustrated in FIG. 3 on the probe applicators (20) and/or respondingto the display on the remote computer (33). It is anticipated that thetreating provider will have several mechanisms available to accomplishsaid acknowledgement, i.e. voice recognition, etc. Acknowledgements bythe treating provider could be required under several circumstances, forexample the protocol is indicating that it is time to advance to thenext sequence of treatment windows requiring the treating provider torelocate and/or utilize different stimulating electrodes. Conceivably,the treating provider may need to respond to the Clinical Resource's(47) response to one of their own inquiries. Device settings may varythroughout the delivery window within the prescribed therapeutic rangeas dictated by protocol settings including: tightly modulated frequency(23) and pulse width (24) with varying stimulation patterns of durationand length of stimulation at any one site to avoid conflicting issues ofaccommodation, i.e. the bodies own ‘adaptability’ while accomplishingthe necessary therapeutic effects.

On a more macroscopic level, the accumulative therapeutic effectprovides a critical initial neuromodulation pattern that affords anecessary level of priming and preconditioning referred to as neuraxialmesoscopic desynchronization and neural facilitation with paired pulsefacilitation of the targeted neuromuscular pathway. In our experience,it is only after this priming and preconditioning that subsequentreparative neuromodulation efforts will be allowed without an attendantdegree of contributory membrane dysfunctions including, but not limitedto, excitotoxicity and other adverse induced mechanisms known to causeor contribute to various known mechanisms of pain.

Referring to FIG. 1, once the preconditioning/priming phase iscompleted, i.e., neuraxial mesoscopic desynchronization followed byneural facilitation of the targeted pathway, the electrotherapeuticneuromodulation of the targeted intervening neuropathways at additionalsites via a neuraxial electrostimulation approach is placementsequenced. One of the underlying goals is the re-establishment ofappropriate cortical and long track sensory integration and relatedthalamic gating dynamics thereby addressing a major subset of commonunderlying mechanisms of the etiology, not just masking the perceptionof pain and/or perpetuating same, of various forms of both chronic andacute pain. Particular emphasis is placed on the central nervous system(CNS), ascending and descending pain pathways and how they are involved,as well as, their interaction with the peripheral nervous system (PNS).Collectively, this ‘intermodality’ approach is designed to reverseapplicable clinicodynamics such as mesoscopic and macroscopic levels ofneuroconduction interference (to include derived heterodyne-basedinfluences), maladaptive thalamic neuroplasticity, other clinicodynamicsof central sensitization and other ‘pain’ enhancing pathologic changesthat commonly subserves pain and tend to escalate related symptomatologyover time, often evolving to chronicity. Intermodality is a term appliedto indicate the Algotron's (10) ability to be simultaneously used withall other mainstream pain treatment modalities and/or approaches incommon use today.

Referring to FIG. 2, the NTENS (18) is applied to the patient (11)transcutaneously with the stimulation being delivered neuraxially bymeans of various forms and types of wired and wireless electrodes, therebeing one pair per output channel with the capacity for multiplechannels. The technique (method) for applying the microcurrentstimulation is referred to as the ‘Neural Tube’ Technique involving oneor more stimulation channels, two outputs (electrodes) per channel. Theuniqueness of this method is based on a ‘neuraxial’ approach coupledwith multiple placements of stimulation at one or more sites dependingon the clinical presentation. A primary state of ‘neuraxial mesoscopicdesynchronization (NMD)’ is achieved coupled with a critical priming andpre-conditioning effect (neural facilitation with paired pulsedfacilitation), and prepares the intervening neuropathways for subsequenttreatment. In the initial sequencing, one electrode/stimulator of thetwo directly coupled forming one channel is placed at the vertex of thehead coupled to the second electrode/stimulator on the sacral midline atthe top of the gluteal cleft. As dictated by the protocol, multiplechannels may be and are often applied simultaneously. Restated, onechannel, the primary channel, targets the intervening pathway from thevertex of the head to the top of the gluteal cleft. The subsequentchannels target additional specific primary and secondary segments ofthe involved symptomatic region including, when appropriate,neurosplanchnic innervations, etc. When using this technique, theelectrodes from each channel should be coupled with one another butnever cross-coupled. As determined by protocol there will be automaticadjustments of stimulation parameters by the stimulation patterngenerator (41) as addressed earlier.

Referring to FIG. 2, the more sophisticated Central Computer (48) withthe Clinical Resource (47) which includes the Clinical Triage Resource(13), AlgoNeuroMatrix (14), Protocol Generator (40) and StimulationPattern Generator (41) further comprises a control program (46) which isembodied as a computer readable code and directs the processor (42) inperforming the functions of the invention. In one presently preferredembodiment, the control program (46) is stored in a computer-usablemedium such as the storage device (45). In another alternativeembodiment, the control program (46) is stored in an integrated memorycircuit, which is in electrical communication with the processor (42).In yet another embodiment, the control program (46) is partially storedin the ROM (43) and partially stored on the above mentioned storagedevice (45). In such an embodiment, the processor (42) initiallyaccesses the ROM (43) upon start up of the system. The control program(46) begins verification and configuration of the other storage devices(45) to locate the remainder of the control program (46). The processor(42) is then directed to the appropriate storage device (45) to retrievethe remainder of the control program (46).

Referring to FIG. 2, the control program (46) and the Clinical Resource(47) programming code encompasses all of the software programmingnecessary to perform the function of the invention and is comprised ofthe Clinical Triage Resource (13), AlgoNeuroMatrix (14), protocolgenerator (40) and stimulation pattern generator (41). In accordancewith the present invention, data of various types are sent to and fromthe Central Computer (48). In all of the embodiments, the respectivestorage devices (38,45) are in electrical communications with andaccessible by their respective processors (35,42).

Referring to FIG. 2, once processed by the Clinical Triage Resource(13), the AlgoNeuroMatrix (14) will analyze the Remote Algotron's data.It will test for ‘best fit’ and adjunctively make patient-specifictreatment recommendations regarding pain management/treatment to theClinical Triage Resource (13). The Clinical Resource (47) which isimpacted by the Clinical Triage Resource (13), AlgoNeuroMatrix, (14),Protocol Generator (40) and Stimulation Pattern Generator (41), isultimately responsible for generating the patient and treatment visitspecific protocol and transmitting directly to the Remote Algotron (15),the Licensee/Provider (12) and will also directly modify settings of theNTENS (18). By conscious design, at no time will a Licensee/Provider(12) be provided a treatment protocol without ultimately being evaluatedby the Clinical Triage Resource (13) before being transmitted.

Referring to FIG. 2, the data files assembled and incorporated intoanalyses by the Clinical Resource (47) are specific to each patient.That patient's unique visit data and recommendations regardingprescribed treatment protocols which are transmitted to the RemoteAlgotron (15), as well as associated reported outcomes comprise thosedata files. The Clinical Resource (47) may prompt for input from theRemote Algotron (15) as well as display other information and displaythis output in a variety of formats. In one presently preferredembodiment, the Clinical Resource (47) employs customary graphical userinterface (GUI) parameters for interaction with common computer hardwaresuch as, but not limited to a mouse and keyboard to communicate with theRemote Algotron (15) through the remote Licensee/Provider Computer (33)to elicit responses in a series of prompts regarding presenting clinicalpatient data, treatment protocol components, in-stage treatment data andvarious forms of dynamic progress reports, including certain trendanalyses and visit specific progress reports.

Referring to FIGS. 1 and 2, directed by the Clinical Triage Resource,the AlgoNeuroMatrix (14) will assist in developing treatment supportsolutions for a given set of clinical data points that have been definedfor similar cases with their particular clinical course and outcomes.After providing the desired performance of a technical system forcertain distinct cases by rules, an artificial intelligence engine willsupply this knowledge, in an adjunctive manner to the Clinical TriageResource (13), to test for ‘best fit’, protocol compliance and clinicaland therapeutic trending purposes. The AlgoNeuroMatrix (14) will besubordinated to and respond to input from the Clinical Triage Resource(13) which is, in part, influenced by the remote feedback monitoringsystems and treating provider data input. The control program (46) willthen be used to loop this information back through the Clinical TriageResource (13) for considerations of refining the treatment protocolbeing developed for a particular patient and visit specific application.Additionally, the resultant information becomes part of the reportsmatrix to the treating provider for purposes of longitudinal clinicaland therapeutic trending.

Although the present invention has been described with reference topreferred embodiments, changes may be made in form without departingfrom the scope of the invention. Having described and illustrated theprinciples of the present invention, it should be apparent that theinvention can be modified in arrangement and detail without departingfrom such principles. The present invention should not be limited, forinstance, to various other physiologic monitoring modalities and toother devices but rather can be applied to any medical device havingparameters than can be remotely programmed responsive to locally orremotely input patient criteria. Accordingly, the scope of the presentinvention shall be governed by the following claims.

1. A central pain management system (Algotron) comprising: a paintreatment system (Remote Algotron); a pain treatment device (NeuraxialTranscutaneous Electrical Nerve Stimulator NTENS); a Central Computer; aClinical Resource including; a clinical-outcomes knowledgebase(AlgoNeuroMatrix), a Clinical Triage Resource, a Protocol Generator, anda Stimulation Pattern Generator; the Algotron further includescombinations of network architectures to coordinate between a patient, aLicensee/Provider, a Licensee/Provider Computer, an internet andreal-time data point streaming.
 2. A pain management system (Algotron)according to claim 1 wherein: the novel pain treatment device is aNeuraxial Transcutaneous Electrical Nerve Stimulator (NTENS) that isprovided operational instructions referred to as a ‘protocol’ from theattached or associated Remote Algotron, a pain treatment system, that isfurther connected to the Algotron.
 3. A pain management system(Algotron) according to claim 1 wherein: the Remote Algotron encompassesan input/output (I/O) interface; several levels of biometric accesssecurity levels identifying and confirming both the patient andprovider; a pain treatment device NTENS; multiple autonomic nervoussystem (ANS monitoring) channels; 4 electromyography channels (EMG ×4monitoring); electrodermal impedance monitoring for constant currentassurance; processor; a ROM/RAM; a display, storage device; and acontrol program.
 4. A NTENS device comprising: a power supply;stimulation outputs having a tightly modulated complex waveform; anasymmetrical sum zero delivery window pattern; a tightly modulatedsquare waveform; alternating polarities; tightly modulated frequencypulse trains and burst patterns; and sets of electrode outputs having aminimum of two channels, and two electrodes per channel; with multiplechannels commonly required with a varying stimulation range.
 5. A NTENSdevice according to claim 4 comprising: a fully functional, programmableelectro-therapy device employable by a Remote Algotron responding totreatment protocols generated by the Clinical Resource and moreparticularly by the protocol generator for treatment of the etiology ofa patient's underlying condition that results in their varying report ofpain and related disabilities not just masking their perception of painand is applied to the patient transcutaneously with the stimulationbeing delivered neuraxially by means of various forms and types of wiredand wireless electrodes, there being one pair per output channel withthe capacity for multiple channels.
 6. A NTENS device according to claim4 wherein: the varying patterns include burst patterns and varyinglengths of trains of varying amplitudes ranging from 0.1 microamps to 60milliamps with a 0.1 microamp resolution.
 7. A NTENS device according toclaim 4 wherein: it has an asymmetrical stimulation pattern, tightlymodulated square waveform with tightly modulated varying pulse widthsand alternating polarities of current to a sum zero over each treatmentdelivery window.
 8. A NTENS device according to claim 4 wherein: thestimulation pattern is designed to have a tightly modulated varyingpulse width from 0.1 microsecond to 500 milliseconds with a 0.1microsecond resolution.
 9. A NTENS device according to claim 4comprising: a delivery window defined as the length of time of a givenplacement sequence of stimulation ranging from a burst pattern of 0.1millisecond to varying asymmetric train patterns of stimulation totalingup to ten (10) minutes per placement site by the NTENS, the stimulationand number of treatment delivery windows is dictated by the prescribedtreatment protocol generated by the Clinical Resource and transmitted tothe Remote Algotron for each individual visit.
 10. A NTENS deviceaccording to claim 4 wherein: the accumulative therapeutic effectprovides a critical initial neuromodulation, such as a neuraxialmesoscopic desynchronization followed by neural facilitation with pairedpulsed facilitation, a pattern that affords a necessary level of primingand preconditioning of the targeted neuromuscular pathway.
 11. A NTENSdevice according to claim 4 wherein: once the preconditioning/primingphase is completed, the electrotherapeutic neuromodulation of thetargeted intervening neuropathways at additional sites via a neuraxialelectrostimulation approach is placement sequenced.
 12. A NTENS deviceaccording to claim 4 wherein: this ‘intermodality’ approach is designedto reverse applicable clinicodynamics such as mesoscopic and macroscopiclevels of neuroconduction interference, including a derivedheterodyne-based influences, maladaptive thalamic neuroplasticity, otherclinicodynamics of central sensitization and other ‘pain’ enhancingpathologic changes that commonly subserves pain and tend to escalaterelated symptomatology over time, often evolving to chronicity.
 13. ANTENS device according to claim 4 wherein: tightly modulated frequenciesutilized range from 0.1 to 5 htz.
 14. A NTENS device according to claim4 wherein: the device settings will vary throughout the delivery windowwithin the prescribed therapeutic range as dictated by protocol settingsincluding tightly modulated frequency and pulse width with varyingstimulation patterns of duration and length of stimulation at any onesite to avoid issues of accommodation, i.e. the bodies own‘adaptability’ while accomplishing the necessary therapeutic effects.15. A NTENS device according to claim 4 wherein: the electrostimulationis delivered through a combination of wired or wireless electrodes,handheld probe electrodes, electrode gloves and/or skin affixedelectrodes such as but not limited to silver-silver chloride, tin orgold disk or adhesive pad electrodes or active (both dry and non-dry)electrodes.
 16. A method for applying the NTENS device comprising thesteps of: applying the microcurrent stimulation technique referred to asthe ‘Neural Tube’ Technique involving one or more stimulation channels,two outputs (electrodes) per channel and is based on a ‘neuraxial’approach coupled with multiple placements of stimulation at one or moresites depending on the clinical presentation.
 17. A method for applyingthe NTENS device according to claim 16 wherein: the initial sequencing,one electrode/stimulator of the two directly coupled forming one channelis placed at the vertex of the head coupled to the secondelectrode/stimulator on the sacral midline at the top of the glutealcleft.
 18. A method for applying the NTENS device according to claim 16wherein: the subsequent channels target additional specific primary andsecondary segments of the involved symptomatic region including, whenappropriate, neurosplanchnic innervations.